Trial Outcomes & Findings for RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT) (NCT NCT02489903)

Last Updated: 2025-03-17

Results Overview

From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

139 participants

Primary outcome timeframe

From start of treatment through death for up to 64 months from Start of Treatment.

Results posted on

2025-03-17

Participant Flow

Participants were recruited based on physician referral at 13 academic medical centers between June 2015 and October 2020. The first participant first visit was June 12, 2015 and the last patient last visit was October 8, 2020.

139 participants provided consent. 118 patients consented under Amendment 01-09. 21 patients were consented on Amendment 10 with 13 randomized in the study. A total of 92 patients under Amendment 01-09 and 13 patients under Amendment 10, combined 107 patients.

Participant milestones

Participant milestones
Measure	RRx-001 + Platinum Doublet (A01-09) 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity	Screening (Pre-Randomization) (A10) Subjects were screened and did not get Randomized
Screening STARTED	118	0	0	21
Screening COMPLETED	94	0	0	13
Screening NOT COMPLETED	24	0	0	8
Randomized and Received Treatment STARTED	94	11	2	0
Randomized and Received Treatment COMPLETED	75	7	2	0
Randomized and Received Treatment NOT COMPLETED	19	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	RRx-001 + Platinum Doublet (A01-09) 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Screening (Pre-Randomization) (A10) Subjects were screened and did not get Randomized
Screening Screen Failure	24	0	8
Randomized and Received Treatment Protocol Violation	0	1	0
Randomized and Received Treatment Baseline Drop Out	3	0	0
Randomized and Received Treatment Withdrawal by Subject	6	2	0
Randomized and Received Treatment Death	10	1	0

Baseline Characteristics

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RRx-001 + Platinum Doublet (A01-09) n=94 Participants 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=11 Participants RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 Participants Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity	Total n=107 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	61.3 years STANDARD_DEVIATION 6.1 • n=7 Participants	75.0 years STANDARD_DEVIATION 2.8 • n=5 Participants	61.6 years STANDARD_DEVIATION 10.9 • n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	100 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	85 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	94 participants n=5 Participants	11 participants n=7 Participants	2 participants n=5 Participants	107 participants n=4 Participants

PRIMARY outcome

Timeframe: From start of treatment through death for up to 64 months from Start of Treatment.

Outcome measures

Outcome measures
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 Participants 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 Participants RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 Participants Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Overall Survival	6.85 Months Interval 5.8 to 8.62	7.6 Months Interval 5.0 to insufficient number of participants with events	7.5 Months Interval 3.0 to insufficient number of participants with events

SECONDARY outcome

Timeframe: Assessed up to 49 months

Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.

Outcome measures

Outcome measures
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 Participants 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 Participants RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 Participants Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Overall Response Rate (ORR)	32 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Assessed up to 49 months

The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months.

Outcome measures

Outcome measures
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 Participants 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 Participants RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 Participants Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Disease Control Rate (DCR)	42 Participants	8 Participants	2 Participants

SECONDARY outcome

Timeframe: Assessed up to 49 months

Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.

Outcome measures

Outcome measures
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 Participants 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 Participants RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 Participants Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Progression Free Survival (PFS)	5.87 months Interval 4.46 to 7.54	6.50 months insufficient number of participants with events	12 months insufficient number of participants with events

Adverse Events

RRx-001 + Platinum Doublet (A01-09)

Serious events: 55 serious events

Other events: 89 other events

Deaths: 89 deaths

RRx-001 + Platinum + RRx-001 (A10)

Serious events: 6 serious events

Other events: 10 other events

Deaths: 10 deaths

Investigator's Choice (A10)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Bryan Oronsky

EpicentRx, Inc

Phone: 858-229-1062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 participants at risk 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 participants at risk RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 participants at risk Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Blood and lymphatic system disorders Anaemia	4.5% 4/89 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Febrile Neutropenia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Thrombocytopenia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Atrial fibrillation	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Supraventricular Tachycardia (SVT)	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Tachycardia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Endocrine disorders Cushing's Syndrome	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Abdominal Pain	4.5% 4/89 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Abdominal Pain upper	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Ascites	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Constipation	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Duodenal Obstruction	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Duodenal ulcer haemorrhage	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Dysphagia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Intestinal perforation	0.00% 0/89 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Obstruction Gastric	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Small Intestinal Obstruction	3.4% 3/89 • Number of events 3 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Death	6.7% 6/89 • Number of events 6 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Generalized Oedema	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Pain	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Pyrexia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Hepatobiliary disorders Cholelithiasis	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Abdominal Infection	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Abscess	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Bacteraemia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Cellulitis	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Clostridium difficile colitis	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Clostridium difficile infection	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Coronavirus Infection	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Gastroenteritis viral	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Influenza	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Lung Infection	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Pneumonia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Sepsis	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Urinary tract infection	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Urosepsis	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hyperglycemia	1.1% 1/89 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hyponatraemia	4.5% 4/89 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Inappropriate antidiuretic hormone secretion	0.00% 0/89 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	100.0% 2/2 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Musculoskeletal and connective tissue disorders Back Pain	2.2% 2/89 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.

Other adverse events
Measure	RRx-001 + Platinum Doublet (A01-09) n=89 participants at risk 4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy	RRx-001 + Platinum + RRx-001 (A10) n=10 participants at risk RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).	Investigator's Choice (A10) n=2 participants at risk Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
Blood and lymphatic system disorders Anaemia	13.5% 12/89 • Number of events 27 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	80.0% 8/10 • Number of events 8 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	100.0% 2/2 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Neutropenia	10.1% 9/89 • Number of events 13 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.0% 3/10 • Number of events 3 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Decreased appetite	12.4% 11/89 • Number of events 18 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pseudoprogression	12.4% 11/89 • Number of events 11 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Psychiatric disorders Mental status changes	0.00% 0/89 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Thrombocytopenia	6.7% 6/89 • Number of events 12 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	40.0% 4/10 • Number of events 6 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Abdominal pain	10.1% 9/89 • Number of events 12 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.0% 3/10 • Number of events 3 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Constipation	22.5% 20/89 • Number of events 23 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Nausea	13.5% 12/89 • Number of events 25 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	40.0% 4/10 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Vomiting	5.6% 5/89 • Number of events 13 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Fatigue	20.2% 18/89 • Number of events 35 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	40.0% 4/10 • Number of events 7 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Infusion related reaction	20.2% 18/89 • Number of events 18 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	40.0% 4/10 • Number of events 7 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	50.0% 1/2 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	10.1% 9/89 • Number of events 12 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Musculoskeletal and connective tissue disorders Back pain	10.1% 9/89 • Number of events 13 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Nervous system disorders Neuropathy peripheral	10.1% 9/89 • Number of events 11 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Nervous system disorders Headache	9.0% 8/89 • Number of events 11 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Respiratory, thoracic and mediastinal disorders Cough	9.0% 8/89 • Number of events 11 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/2 • Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug. All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.